ANZCTR search results

The primary purpose of this pilot trial is to evaluate the efficacy and safety of Hybrid-APC ablation for the treatment of Barrett's oesophagus. Who is it for? You may be eligible to participate in this trial if you are aged 18-85 years and have been diagnosed with Barrett's oesophagus with low grade dysplasia, high grade dysplasia or T1a adenocarcinoma. Study details All participants enrolled in this trial will receive the Hybrid-APC ablation procedure which involves an gastroscopy with use of so called Hybrid-APC ablation. This means that a saline solution (NaCl 0.9%) will be injected into the submucosal lining of the affected area and thereafter the affected tissue will be coagulated using APC. Participants will then be followed up every three months during 5 years of follow-up to assess disease progression and whether any additional procedures are required. It is hoped that the findings from this pilot trial will provide preliminary information regarding the safety and efficacy of ablation for Barrett's oesophagus, which may be used to inform larger clinical trials in the future.

Primary Objective: To describe and determine the mechanism by which a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alters the kinetics of Lp(a) and its protein components, as well as the concentrations and kinetics of apoB-100 containing lipoproteins in statin-treated patients with inherited high plasma Lp(a) who are at moderate-to-high risk of cardiovascular disease (CVD). Hypothesis: Inhibition of PCSK9 increases apoB-100 catabolism and decreases hepatic secretion of apoB-100, and hence, the pool of apoB-100 available for binding to apo(a), resulting in a decrease in the production and plasma concentrations of Lp(a). Study Design: A 12-week (treatment period) single-arm, open-label, pre- and post-designed pilot study of the effect of Alirocumab (two-weekly subcutaneously injected dose of 150 mg) on plasma Lp(a) concentration and metabolism in 21 patients with inherited high plasma Lp(a). The CVD risk (low or moderate-to-high) of participants will be determined based on the Australian National Vascular Disease Prevention Alliance (NVDPA) Guidelines for management of absolute cardiovascular disease risk. Participant Numbers: N=21 participants to complete the study

Individuals with depression and metabolic syndrome are 6.6 times more likely to develop type 2 diabetes within 5 years compared to individuals without either condition. Thus, early, robust and targeted interventions are warranted to alleviate symptoms of depression and improve the metabolic health of these at-risk individuals. The primary aims of this project are to determine the effects of progressive resistance training on insulin resistance (measured using the Homeostatic Model of Assessment-2) and depressive symptoms [assessor-rated Hamilton Depression Rating Scale (HDRS), Patient Health Questionnaire (PHQ-9) and Center for Epidemiologic Studies Depression Scale (CES-D) in adults with co-existing metabolic syndrome and major depressive disorder. Participants will be randomized to receive either progressive resistance training (PRT), 3 days per week for 12 weeks in addition to usual care from their GP, or referred to their GP for usual care. Participants randomised to the control intervention will be referred to their GP for management of their depression and metabolic syndrome. Blinded assessments will occur pre, and post intervention. This will be the first trial of PRT for individuals with co-existing major depressive disorder, metabolic syndrome and impaired glucose tolerance, and only the 5th trial of PRT in clinical depression. Primary Hypotheses 1. 12 weeks of PRT will significantly reduce insulin resistance, measured via Homeostatic Model of Assessment-2 (HOMA2-IR) compared to controls referred for General Practitioner (GP) care. 2. 12 weeks of PRT will significantly improve therapist-rated depressive symptoms [Hamilton Depression Rating Scale (HDRS)] as well as self-rated symptoms [Patient Health Questionnaire (PHQ-9)] and Center for Epidemiologic Studies Depression Scale (CES-D) compared to controls referred for GP care. Secondary Hypotheses 1. 12 weeks of PRT will significantly reduce glucose and insulin area under the curve during an oral glucose tolerance test (OGTT) compared to controls referred for GP care. 2. 12 weeks of PRT will significantly reduce glycated haemoglobin (HbA1c) compared to controls referred for GP care. 3. 12 weeks of PRT will significantly increase lean body mass (LBM) and decrease central adiposity compared to controls referred for GP care. 4. 12 weeks of PRT sill significantly improve central haemodynamics compared to controls referred for GP care. 4. Reductions in depressive symptoms will be associated with reductions in HOMA2-IR. 5. Improvements in body composition (increases in lean tissue and reductions in central adiposity), and reductions in systemic inflammation and serum cortisol will be independently associated with improvements in metabolic profile and depressive symptoms.

The deepest and most recuperative part of sleep, SWS, begins to decline from mid-adulthood. These reductions include both duration and the depth of SWS. This impairment may be linked to changes in cognitive performance. Therefore, we hypothesize that enhancing SWS via acoustic stimuli leads to improvements in cognitive performance.

The aim of the study was to compare the postoperative analgesia of continuous infusion of Bupivacaine via wound catheters in newborn babies undergoing major abdominal surgery for congenital or acquired gastrointestinal conditions.

The aim of the study is to develop and pilot a mindfulness and compassion based group intervention for youth with psychotic experiences. The program has been designed as an conjunct to treatment as usual. It specifically focuses on developing mindfulness and compassion skills in relation to attenuated psychotic symptoms, depression, anxiety, stress, self-criticism, social and daily functioning.

The proof of concept pilot explores the effectiveness of Remote Patient Monitoring (RPM) to support patients with COPD and Diabetes. The IT system used in this pilot project is a web based platform that can be accessed from any internet connected device. The patient, when accessing the platform, will be directed to their personalised care plan that has a questionnaire designed to educate and guide the client to monitor and support their own health. The peripheral devices that link to the system, enable the monitoring of clinical signs and symptoms such as SaO2, blood pressure and blood glucose measures. For the health service clinicians accessing the platform, the RPM system identifies in real time which clients have recorded results at that point in time and which have not, it provides an indication of which results are at variance to the result parameters set for each individual;, thus enabling a rapid and timely response. The RPM system generates individualized reporting that allows the clinicians to monitor trends within a client’s health care over time, enabling treatment to be appropriately adapted as and if required. The pilot was supported by a Data Safety Monitoring Board and is aim at evaluating the effectiveness of the tele-health intervention

People with Chronic Obstructive Pulmonary Disease (COPD) or asthma usually experience swelling (inflammation) in their airways (breathing tubes), that makes is difficult to breathe. This inflammation can worsen their condition and lead to further medical problems. An inflammatory cell called the neutrophil is often present in the airways of people with COPD or asthma, and when activated these cells release molecules that lead to swelling and damage of the lungs. Neutrophils also release ‘extracellular traps’ called NETs, which look like a spider web and are made up of the cell’s DNA (the genetic code which carries all the information about how we look and function) and other inflammatory molecules. These traps can kill bacteria, however if they are not cleared they are toxic to the lungs. We have shown a build-up of NETs in sputum from patients with COPD and asthma. In another lung disease called cystic fibrosis, NETs are broken down and cleared by a treatment called Pulmozyme, which improves lung function and decreases lung attacks. This study will investigate NETs in COPD and asthma, their effects on the lungs, and whether treatment with Pulmozyme can improve symptoms.

The primary aim of this study is to characterise the effects of prolonged sitting on femoral artery endothelial function in patients with type 2 diabetes and to investigate the potentially beneficial effects of (i) 3 min every 30 min; and (ii) 6 min every 60 min of simple resistance activity (SRA) breaks on endothelial function, and postprandial glucose, insulin and lipid profiles in comparison to prolonged sitting. Secondary outcome measures will also provide information on the potential signalling pathways (insulin and SNS-mediated vasoconstriction pathways) that are contributing to the decline in vascular function with prolonged sitting. For this, we propose to undertake a randomised crossover trial in twenty four inactive and injury-free overweight/obese adults aged between 35-70 years diagnosed with type 2 diabetes. This study will involve three acute experimental conditions (each of 8 hours duration), separated by a minimum 6-day washout period to account for any residual physiological effects of the intervention. Each participant will complete three conditions, involving (i) Uninterrupted Sitting - 8 hours of prolonged sitting; (ii) Simple Resistance Exercises (30) + Interrupted Sitting: 8 hours of sitting with 3 minutes of simple resistance activity breaks every 30 minutes; and (iii) Simple Resistance Exercises (60) + Interrupted Sitting: 8 hours of sitting with 6 minutes of simple resistance activity breaks every 60 minutes. Standardised breakfast and lunch will be provided for the test. Dinner will also be provided prior to each condition, and dinner and breakfast will be provided following each condition. Vascular function will be directly measured using Flow Mediated Dilation (FMD). FMD is a widely-used non-invasive method to describe endothelial function and vasodilation of an artery following ischaemia. Participants will be fitted with a flash glucose monitoring system (Libre) to wear from the first visit to the day after the final study visit. During the experimental conditions, venous blood samples will be collected every 30 minutes and blood markers of endothelial function will also be measured, including endothelin-1 production. Changes in Sympathetic Nervous System (SNS) activity may help to explain any differences in FMD over the day and between conditions. SNS activity will be indirectly measured via catecholamine levels in the blood. Plasma markers of cardiovascular health and inflammation will also be measured, as well as blood pressure (during experimental sessions). At the conclusion of each condition, participants will be fitted with a 24 hour ambulatory blood pressure monitor (ABPM).

The purpose is to investigate the role of tranexamic acid (TA) in the setting of intra-capsular neck of femur fractures which is the type of broken hip. (TA) is a medicine (synthetic type of amino acid lysine) which is used to prevent excessive blood loss during surgery. (TA) is commonly used in elective joint replacement (Total hip and total knee replacement) and is recognized to reduce blood loss during surgery and the need of blood transfusion afterward. However we do not have as much evidence on its effect in the setting of broken bone in hip. We intend to explore the relationship between its use and blood loss after surgery and the need for blood transfusion. If the patient agrees to participate in this study, they will be asked to sign the Person Responsible Consent Form. This study will be conducted over 1 to 2 years. The treatment being investigated in this study is three doses of (TA) given intravenously at the time of surgery and 8 and 16 hours after surgery. Study participants are put into two groups and given different treatments, and the results are compared to see whether one treatment is better. To ensure the groups are similar to start with, a computer allocates each study participant into a group randomly, Neither the doctor nor the study participant can decide which treatment the participant receives. Once the patient agrees to participate in this trial, they will then be randomly allocated a number which decides whether they receive either 3 doses of (TA) (intervention group) or not. The first dose is given at the time of surgery and next two 8 and 16 hours post surgery. Study hypothesis 1. Administration of intravenous TA in patients presenting with intra-capsular neck of femur fractures undergoing hemiarthroplasty or total hip arthroplasty reduces the rate of post-operative blood loss and blood transfusion. 2. The intravenous administration of TA is safe and is not associated with an increase in the rates of post-operative venous thromboembolic, cardiovascular or cerebrovascular events in this population. Aims This study aims to provide high quality evidence of the relative benefits and risks of the use of TA in the setting of emergency hemiarthroplasty or THA for the management of NOF fractures. The results of this study will support and influence the future treatment of this common injury. Primary outcome 1. To determine the effect of administration of a three dose protocol of intravenous TA on the incidence of acute postoperative blood transfusion in patients presenting with intra capsular neck of femur fractures undergoing hemi or THA Secondary outcomes 1.To assess the incidence of acute post-operative venous thromboembolic (deep vein thrombosis, pulmonary embolism), cardiovascular (acute myocardial infarction) and cerebrovascular events (stroke) in this study population 2.To assess whether the administration of TA in a three-dose intravenous protocol leads to a reduction in post-operative drop in Haemoglobin.